Prediction of Cmax [Dissolution / BCS / IVIVC]
Dear Members
Regards
This is my first post to this forum
We are working on a moleculae and in BE studies we found that
AUC0-t= 95 (83-109) AUC0-Inf= 91 (79-105) and Cmax= 105 (95-115). In this study using Level A IVIVC correlation we got the r2value of 0.976.
Now we want to have a new formulation in which we want to increase the AUC by higher initial release but now we are thinking that our Cmax can get affected too.
Is there any way to predict the Cmax of the next batch using IVIVC data (regression line equation) and Dissolution profile of proposed and existing batches.
Here are the datas
Mean Plasma Profile
Dissolution profles
Can we predict the Cmax for the proposed batch using the the above data...
Drug follows one CBM
Thanks in advance
Edit: reformatted using BBCodes (tabs may confuse some text-browsers). [Helmut]
Regards
This is my first post to this forum
We are working on a moleculae and in BE studies we found that
AUC0-t= 95 (83-109) AUC0-Inf= 91 (79-105) and Cmax= 105 (95-115). In this study using Level A IVIVC correlation we got the r2value of 0.976.
Now we want to have a new formulation in which we want to increase the AUC by higher initial release but now we are thinking that our Cmax can get affected too.
Is there any way to predict the Cmax of the next batch using IVIVC data (regression line equation) and Dissolution profile of proposed and existing batches.
Here are the datas
Mean Plasma Profile
Time Reference Test
0.00 0.00 0.00
1.00 182.52 48.47
2.00 565.79 428.95
3.00 809.47 682.06
4.00 1005.12 929.53
5.00 1434.22 1353.42
6.00 1506.14 1571.97
7.00 1549.33 1624.28
8.00 1645.65 1712.17
9.00 1681.64 1797.18
10.00 1703.32 1771.66
11.00 1645.02 1740.31
12.00 1603.28 1670.32
13.00 1525.32 1615.74
14.00 1537.53 1583.79
16.00 1359.26 1379.78
24.00 734.25 594.64
36.00 167.872 151.341
--------------------------Dissolution profles
Time Ref First (bio batch) Second (proposed)
0 0 0 0
1 11 6 17
2 18 18 26
4 30 36 42
8 51 58 62
12 71 71 77
16 86 81 87
20 96 90 93
24 102 96 98
---------------------------------------------Can we predict the Cmax for the proposed batch using the the above data...
Drug follows one CBM
Thanks in advance
Edit: reformatted using BBCodes (tabs may confuse some text-browsers). [Helmut]
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Complete thread:
- Prediction of Cmaxluvblooms 2008-07-22 06:43
- Prediction of Cmax martin 2008-07-23 10:24
- Prediction of Cmax luvblooms 2008-07-24 05:57
- Prediction of Cmax martin 2008-07-24 09:56
- Prediction of Cmax Helmut 2008-07-24 14:18
- Prediction of Cmax martin 2008-07-25 08:48
- Prediction of Cmax Helmut 2008-07-24 14:18
- Prediction of Cmax martin 2008-07-24 09:56
- Prediction of Cmax luvblooms 2008-07-24 05:57
- Prediction of Cmax martin 2008-07-23 10:24
